Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole

PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

June 18, 2018

Primary Completion Date

October 13, 2019

Study Completion Date

October 13, 2019

Conditions
Transplant-Related Hematologic MalignancyLeukemia, AcuteMyelodysplastic SyndromesGraft Vs Host DiseaseFungal Infection
Interventions
DRUG

"Conditioning treatment Thiotepa-Treosulfan-Fludarabine"

Thiotepa iv 5 mg/kg/bid (total dose TD 10 mg/kg) day -3,-2; Treosulfan iv 14g/mq/day (TD 42 g/mq) as a single daily dose day -6, -5, -4; Fludarabine iv 30 mg/m2 (TD 150 mg/m2) day -6, -5, -4, -3, -2. Thiotepa TD 5 mg/kg and treosulfan TD 36 g/mq dose reduction according to age \> 65 years.

PROCEDURE

PBSC graft

(target 4-8 × 106 CD34+ cells/kg patient body weight)

DRUG

GvHD prophylaxis

"Sirolimus orally, monitored two times a week to maintain a target therapeutic plasma level of 8-15 ng/ml from day +5.~Mycophenolate 15 mg/kg bid i.v. or per os day +5 through +28. Cyclophosphamide 50 mg/kg i.v. day +3+4. Mesna: \>80% of the cyclophosphamide dose in 3 divided doses from day +3 daily through day +5."

DRUG

Primary antifungal prophylaxis

Posaconazole delayed-release tablet \[available in 100 mg tablets\]: 300 mg twice daily on the first day followed by a maintenance dose of 300 mg once a day, starting on the day 0 to day 85.

Trial Locations (1)

20132

Ospedale San Raffaele, Milan

All Listed Sponsors
lead

Ciceri Fabio

OTHER

NCT03434704 - Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole | Biotech Hunter | Biotech Hunter